tranexamic acid

Generic: tranexamic acid

Labeler: emcure pharmaceuticals limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name tranexamic acid
Generic Name tranexamic acid
Labeler emcure pharmaceuticals limited
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

tranexamic acid 1 g/10mL

Manufacturer
Emcure Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 14593-318
Product ID 14593-318_996040a7-8eaa-4dcc-ba36-5c37d4db8113
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203521
Listing Expiration 2026-12-31
Marketing Start 2024-10-28

Pharmacologic Class

Established (EPC)
antifibrinolytic agent [epc]
Physiologic Effect
decreased fibrinolysis [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 14593318
Hyphenated Format 14593-318

Supplemental Identifiers

RxCUI
238720
UPC
0314593318016
UNII
6T84R30KC1
NUI
N0000175634 N0000175632

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name tranexamic acid (source: ndc)
Generic Name tranexamic acid (source: ndc)
Application Number ANDA203521 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 1 g/10mL
source: ndc
Packaging
  • 10 VIAL in 1 CARTON (14593-318-01) / 10 mL in 1 VIAL
source: ndc

Packages (1)

14593-318-01 10 VIAL in 1 CARTON (14593-318-01) / 10 mL in 1 VIAL

Ingredients (1)

tranexamic acid (1 g/10mL)

Linked Drug Pages (1)

Tranexamic Acid ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "996040a7-8eaa-4dcc-ba36-5c37d4db8113", "openfda": {"nui": ["N0000175634", "N0000175632"], "upc": ["0314593318016"], "unii": ["6T84R30KC1"], "rxcui": ["238720"], "spl_set_id": ["ceea739a-21dd-4c3a-9ef6-2b7ab2bdd95a"], "pharm_class_pe": ["Decreased Fibrinolysis [PE]"], "pharm_class_epc": ["Antifibrinolytic Agent [EPC]"], "manufacturer_name": ["Emcure Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL in 1 CARTON (14593-318-01)  / 10 mL in 1 VIAL", "package_ndc": "14593-318-01", "marketing_start_date": "20241028"}], "brand_name": "Tranexamic Acid", "product_id": "14593-318_996040a7-8eaa-4dcc-ba36-5c37d4db8113", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Antifibrinolytic Agent [EPC]", "Decreased Fibrinolysis [PE]"], "product_ndc": "14593-318", "generic_name": "Tranexamic Acid", "labeler_name": "Emcure Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Tranexamic Acid", "active_ingredients": [{"name": "TRANEXAMIC ACID", "strength": "1 g/10mL"}], "application_number": "ANDA203521", "marketing_category": "ANDA", "marketing_start_date": "20241028", "listing_expiration_date": "20261231"}